A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline

The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.

Completed

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Woodville South, South Australia, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion criteria

Subjects with clinically significant, recent cardiovascular disease.

Treatment and study plan

varenicline (CP-526,555)

Drug

Primary outcomes

Summarization of safety data in smokers treated with either varenicline or placebo.

Secondary outcomes

Information will be collected for the 7 day point prevalence of smoking cessation.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation

Important dates

Study start: 2003
Study completion: 2005
First posted: Sep 2, 2005
Registry last updated: Jun 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed